The Emergo Group Learning Library

The Emergo Learning Library contains a wealth of articles written by Emergo Group plus intenational medical device and IVD regulations and guidance documents. Most documents are in English. To stay current on the latest quality and regulatory issues facing the device industry, subscribe to our eJournal Update on international regulatory issues.

Articles on Quality Assurance and Regulatory Affairs

Informative articles on quality assurance and regulatory issues written by Emergo Group.

Medical Device Regulations in AUSTRALIA

Medical device and IVD regulations published by Australia's Therapeutic Goods Administration (TGA).

Medical Device Regulations in CANADA

Medical device and IVD regulations published by Health Canada.

Medical Device Regulations in CHINA

English language translations of key medical device regulations issued by the SFDA.

Medical Device Regulations in EUROPE

Medical Devices Directives and MEDDEV Guidance documents for Europe.

Medical Device Regulations in JAPAN

List of Ordinances and Notifications from the Japanese Ministry of Health, Labour and Welfare (MHLW).

Medical Device Regulations in the UNITED STATES

Medical device and IVD regulations published by the US Food and Drug Administration (FDA).